FDA Approves Pavblu for Retinal Conditions
Sep 17, 2024 · Pavblu was developed by Amgen and comes shortly after the FDA approved Enzeevu (aflibercept-abzv) in August 2024. 2 All 5 aflibercept biosimilars were approved in 2024, beginning with Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis' Opuviz (aflibercept-yszy) in May 2024, followed by Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb) in July 2024 and Enzeevu. 3,4
Fourth Ustekinumab Biosimilar, Otulfi, Approved in US
Sep 30, 2024 · The FDA has approved the fourth ustekinumab biosimilar, ustekinumab-aauz (Otulfi) from Formycon and Fresenius Kabi, referencing Stelara (Johnson & Johnson [J&J]). 1 The approval covers Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Ustekinumab is a human monoclonal antibody targeting IL-12 and IL-23.
FDA Approves Steqeyma: The Seventh Stelara Biosimilar
Dec 18, 2024 · The approval represents the seventh biosimilar approval for a Stelara competitor. 2 Steqeyma follows Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce), the last of which was approved at the beginning of December 2024. 3 ...
FDA Approves Imuldosa, a Biosimilar to Stelara
Oct 11, 2024 · Stelara is one of the highest-grossing biologics in the US, generating $10.86 billion globally in 2023. Additionally, US sales for Stelara reached $6.4 billion in 2022, according to Johnson & Johnson's annual financial report.It’s also 1 of the first 10 medications selected by CMS for drug price negotiation, which will go into effect at the start of 2026.
FDA Approves First Denosumab Biosimilars - Center for Biosimilars
Mar 5, 2024 · The FDA has approved Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US. 1 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.. The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in February 2023.
Future Biosimilar Trends, Challenges, and Opportunities
Sep 29, 2024 · Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
Despite Steep Discounts, Humira Biosimilars Are Priced More Than ...
Jul 17, 2023 · Throughout 2023, 9 FDA-approved adalimumab biosimilars are projected to enter the US market. As of the second week of July 2023, 8 had entered the market, beginning with Amgen’s Amjevita (adalimumab-atto) in January. Amjevita launched with a dual price strategy, where 2 versions of the drug would launch at 2 different prices (5% and 55% lower than the current price of Humira) to both entice ...
Breaking Down Biosimilar Barriers: Interchangeability
Nov 14, 2024 · The Impact of the Interchangeability Designation on Patient Biosimilar Access. On June 20, 2024, the FDA published updated draft guidance titled “Consideration for Demonstrating Interchangeability with a Reference Product: Update.” The guidance describes considerations regarding a switching study, or studies, intended to support that a biological product is interchangeable with the ...
Samsung Bioepis' Eculizumab Biosimilar Approved in Europe
May 31, 2023 · The European Commission has granted marketing authorization to Samsung Bioepis' biosimilar referencing Soliris (eculizumab). The product, dubbed Epysqli, is the first hematology biosimilar from Samsung Bioepis to be approved in the European Union.
Product Approvals and Launches - Center for Biosimilars
After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the company, the 10th biosimilar to reference Humira, and the third interchangeable adalimumab biosimilar.